Drug Development and Industrial Pharmacy 2015-06-01

Effect of X-ray exposure on the pharmaceutical quality of drug tablets using X-ray inspection equipment.

Kazuaki Uehara, Tatsuaki Tagami, Itaru Miyazaki, Norikazu Murata, Yoshifumi Takahashi, Hiroshi Ohkubo, Tetsuya Ozeki

文献索引：Drug Dev. Ind. Pharm. 41 , 953-8, (2015)

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摘要

X-ray inspection equipment is widely used to detect missing materials and defective goods in opaque containers. Its application has been expanded to the pharmaceutical industry to detect the presence of drug tablets in aluminum foil press-through packaging. However, the effect of X-rays on the pharmaceutical quality of drug tablets is not well known.In this study, the effect of X-rays on the pharmaceutical quality of drug tablets was investigated.Exposure of acetaminophen, loxoprofen and mefenamic acid tablets to X-ray doses of 0.34 mGy (thrice the dose by X-ray scanning) to 300 Gy (maximum dose from our X-ray equipment) was demonstrated, and the samples were evaluated by formulation tests.Exposure to X-rays did not affect the pharmaceutical quality of the drug content. The samples exposed to X-rays exhibited almost the same profile in formulation tests (dissolution test, disintegrating test and hardness test) as control samples (0 Gy). The combination of X-ray exposure with accelerated temperature and humidity tests (six months) also did not affect the pharmaceutical quality. The color change of light-sensitive drugs (nifedipine and furosemide tablets) after X-ray exposure was negligible (< 1.0). In contrast, tablet color was remarkably changed by light from a D65 lamp.The X-ray scanning and X-ray exposure under our experimental conditions did not affect the pharmaceutical quality of drug tablets.